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Clinical trials for Methotrexate

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    1,059 result(s) found for: Methotrexate. Displaying page 1 of 53.
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    EudraCT Number: 2018-004287-56 Sponsor Protocol Number: CHUBX2016/44 Start Date*: 2019-11-21
    Sponsor Name:CHU de Bordeaux
    Full Title: Randomized placebo-controlled trial comparing Methotrexate vs. Methotrexate/Metformin association in rheumatoid arthritis patients: METorMET² study
    Medical condition: rheumatoid arthritis (RA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004870 10039075 Rheumatoid arthritis and associated conditions HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2004-002157-30 Sponsor Protocol Number: 01-03-TL-715-005 Start Date*: 2004-12-01
    Sponsor Name:Takeda Europe R&D Centre Ltd. (TEuR&D)
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis
    Medical condition: Rheumatoid Arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) DK (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2004-002662-38 Sponsor Protocol Number: ZD1839IL/0704 Start Date*: 2004-11-12
    Sponsor Name:AstraZeneca AB
    Full Title: A PHASE III RANDOMISED, STRATIFIED, PARALLEL-GROUP, MULTI-CENTRE, COMPARATIVE STUDY OF ZD1839 (IRESSA®) 250 MG AND 500 MG VERSUS METHOTREXATE FOR PREVIOUSLY TREATED PATIENTS WITH SQUAMOUS CELL CARC...
    Medical condition: squamous cell carcinoma of the head and neck
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) LT (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2020-000462-41 Sponsor Protocol Number: MTXRA Start Date*: 2021-02-09
    Sponsor Name:Västerbotten county
    Full Title: Efficacy, tolerability and preferences of peroral or subcutaneous methotrexate in patients with early rheumatoid arthritis – a randomized register based multicenter study
    Medical condition: Rheumatoid arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-000591-97 Sponsor Protocol Number: CLSG-CNS-001 Start Date*: 2015-06-03
    Sponsor Name:Kooperativní lymfomová skupina, o.s.
    Full Title: Study evaluating relapses in central nervous system in patients with diffuse large B-cell lymphoma treated with chemotherapy with or without CNS prophylaxis. Multicentric, prospective randomized p...
    Medical condition: Diffuse large B-cell lymphoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012818 Diffuse large B-cell lymphoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003334-27 Sponsor Protocol Number: M13-545 Start Date*: 2015-12-11
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumato...
    Medical condition: Moderately to Severely Active Rheumatoid Arthritis (RA)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) SI (Completed) ES (Ongoing) GR (Completed) LT (Completed) BE (Completed) CZ (Completed) IE (Completed) LV (Completed) PL (Completed) GB (GB - no longer in EU/EEA) PT (Completed) HU (Completed) FI (Prematurely Ended) RO (Ongoing) HR (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-003753-56 Sponsor Protocol Number: 04WH19 Start Date*: 2005-05-31
    Sponsor Name:King's College Hospital NHS Foundation Trust
    Full Title: Randomised double blind control trial of single dose methotrexate versus expectant management in women with tubal ectopic pregnancy
    Medical condition: Tubal ectopic pregnancy
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-000922-59 Sponsor Protocol Number: IM101-043 Start Date*: 2004-12-01
    Sponsor Name:Bristol Myers Squibb International Corporation
    Full Title: A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination with Methotrexate in Controlling Disease Activity in Subjects wit...
    Medical condition: Rheumatoid Arthrithis, Nos
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed) CZ (Completed) ES (Completed)
    Trial results: Removed from public view
    EudraCT Number: 2016-002344-16 Sponsor Protocol Number: RR16/209 Start Date*: 2018-06-28
    Sponsor Name:University of Leeds
    Full Title: Targeted treatment early with etanercept (biosimilar) plus methotrexate or methotrexate with T2T care for DMARD-naïve early RA patients. A prospective, longitudinal cohort study with an embedded pi...
    Medical condition: Rheumatoid Arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2004-000563-96 Sponsor Protocol Number: 0881A-101548 Start Date*: 2004-11-12
    Sponsor Name:Wyeth Pharmaceuticals
    Full Title: A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHE...
    Medical condition: Rheumatoid Arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) SE (Completed) NO (Completed) FI (Completed) ES (Completed) AT (Completed) IE (Completed) IT (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2004-000106-41 Sponsor Protocol Number: CXA100750 Start Date*: 2004-09-07
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A study to investigate the effect of GW406381 on methotrexate pharmacokinetics in patients treated with methotrexate for rheumatoid arthritis
    Medical condition: The patients entering the trial have rheumatoid arthritis although treatment of the disease itself is not under investigation in this study.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2020-001899-14 Sponsor Protocol Number: UKER-ATTRACTOR-01 Start Date*: 2020-08-18
    Sponsor Name:Universitätsklinikum Erlangen
    Full Title: A prospective, randomized, controlled, open label, assessor-blinded, parallel-group Phase III clinical trial to evaluate the impact of tapering systemic immunosuppressive therapy in a treat-to-targ...
    Medical condition: Psoriatic arthritis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10028395 - Musculoskeletal and connective tissue disorders 10037162 Psoriatic arthropathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-006728-20 Sponsor Protocol Number: TAYS1002 Start Date*: 2007-05-31
    Sponsor Name:Moorfields Eye Hospital
    Full Title: The use of intraocular methotrexate to treat uveitis: a safety and efficacy study
    Medical condition: Uveitis (inflammatory eye disease)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10046851 Uveitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-004148-31 Sponsor Protocol Number: PREDMETH_NL71782.078.19 Start Date*: 2020-02-26
    Sponsor Name:Erasmus Medisch Centrum Dept. of Pulmonology
    Full Title: The PREDMETH trial: Effectiveness of methotrexate versus prednisone as first-line therapy for pulmonary sarcoidosis – A randomized controlled trial
    Medical condition: pulmonary sarcoidosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-004869-24 Sponsor Protocol Number: 20130207 Start Date*: 2015-12-09
    Sponsor Name:Amgen Inc.
    Full Title: A Multicenter Double-Blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis.
    Medical condition: Psoriatic arthritis
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004859 10037160 Psoriatic arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) GR (Completed) GB (Completed) PT (Completed) HU (Completed) CZ (Completed) BG (Completed) PL (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-004868-38 Sponsor Protocol Number: 20110186 Start Date*: 2016-01-26
    Sponsor Name:Amgen Inc.
    Full Title: A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.
    Medical condition: Rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    18.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) CZ (Completed) HU (Completed) PT (Completed) BG (Completed) ES (Completed) FR (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-003054-26 Sponsor Protocol Number: TAK-783/EC201 Start Date*: 2007-08-31
    Sponsor Name:Takeda Global R&D (Europe) Ltd
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms of in Subjects with Rheumatoid A...
    Medical condition: Rheumatoid arthritis (RA)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) LV (Completed) HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-008171-34 Sponsor Protocol Number: CNTO1275PSO4004 Start Date*: 2009-09-01
    Sponsor Name:Janssen-Cilag EMEA Medical Affairs
    Full Title: AN EXPLORATORY TRIAL TO ASSESS NATURALISTIC SAFETY AND EFFICACY OUTCOMES IN PATIENTS TRANSITIONED TO USTEKINUMAB FROM PREVIOUS METHOTREXATE THERAPY (TRANSIT)
    Medical condition: moderate to severe plaque psoriasis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10037153 Psoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) AT (Completed) SE (Completed) BE (Completed) HU (Completed) LT (Completed) DK (Completed) FI (Completed) FR (Completed) SK (Completed) PT (Completed) ES (Completed) GB (Completed) BG (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-005260-20 Sponsor Protocol Number: ML28096 Start Date*: 2012-06-28
    Sponsor Name:Roche Products Limited
    Full Title: Randomised, Phase IV, placebo-controlled, comparative study to evaluate the efficacy and safety of tapering methotrexate (MTX) dosage versus maintaining the dosage in patients with severe active rh...
    Medical condition: Adult Rheumatoid Arthritis (RA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-005214-19 Sponsor Protocol Number: S127AMCGolimumabPsA Start Date*: 2013-06-20
    Sponsor Name:Academic Medical Center, Department of Rheumatology
    Full Title: A randomized, double-blind, placebo-controlled trial of golimumab+methotrexate versus methotrexate alone in methotrexate-naïve patients with psoriatic arthritis
    Medical condition: active psoriatic arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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